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[Antihemophilic Factor (Recombinant), PEGylated] Lyophilized Powder for Reconstitution for Intravenous Injection


ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-use vials containing nominal (approximate) potencies of 250, 500, 1000, or 2000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.

When reconstituted with 5 mL sterile water for injection, the final solution contains the following excipients and stabilizer in targeted amounts per vial:

Stabilizer and Excipient 5 mL Reconstitution Target
Tris (hydroxymethyl) aminomethane 6.1 mg
Calcium Chloride 1.2 mg
Mannitol 160 mg
Sodium Chloride 26.3 mg
Trehalose Dihydrate 40 mg
Glutathione .04 mg
Histidine 7.8 mg
Polysorbate 80 0.5 mg

ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700 - 8000 IU/mg protein.

ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa). [see CLINICAL PHARMACOLOGY]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues.

The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.

Last reviewed on RxList: 3/30/2017
This monograph has been modified to include the generic and brand name in many instances.

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